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FDA 510(k)

LACTOSORB TRAUMA PLATING SYSTEM

K-Number: K955729 · 1996-02-14

ApplicantPoly-Medics,Inc.
Decision Date1996-02-14
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

LACTOSORB TRAUMA PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Poly-Medics,Inc.. It received FDA 510(k) clearance on 1996-02-14 under 510(k) number K955729. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the LACTOSORB TRAUMA PLATING SYSTEM?

LACTOSORB TRAUMA PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-02-14. The listed applicant is Poly-Medics,Inc.. The 510(k) number is K955729.

When did LACTOSORB TRAUMA PLATING SYSTEM receive FDA 510(k) clearance?

LACTOSORB TRAUMA PLATING SYSTEM received FDA 510(k) clearance on 1996-02-14, under 510(k) number K955729.

Who is the listed applicant for LACTOSORB TRAUMA PLATING SYSTEM?

The FDA 510(k) record lists Poly-Medics,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LACTOSORB TRAUMA PLATING SYSTEM?

The FDA product code for LACTOSORB TRAUMA PLATING SYSTEM is HRS.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Poly-Medics,Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960988LACTOSORB TRAUMA PLATING SYSTEMK954443LACTOSORB SUTURE ANCHORK951658LACTOSORB POP RIVETK934861HARD TISSUE REPLACEMENT (HTR) GRANULAR

Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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